A Positive Activity Intervention to Promote Wellbeing in Romanian Immigrants

July 14, 2015 updated by: Universitat Jaume I

A Positive Activity Intervention to Promote Optimism and Psychological Wellbeing in Romanian Immigrants

This study aims to test the efficacy of an intervention focused on promoting positive emotions (Best Possible Self - BPS) to improve the psychological wellbeing of Romanian immigrants living in Spain. It is hypothesized that the BPS intervention will significantly improve a series of positive mental health outcomes, i.e., optimism, future expectancies, and affect, compared to the Control group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Previous studies have shown that groups of immigrants may face a series of problems unique to the process of immigration, such as working, legal, social, and mental and physical health problems.

BPS is a guided imagery exercise that requires participants to envision themselves in the future, achieving desired goals in different areas of their lives. This exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population. Taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study in order to replicate the findings about the effects of BPS on optimism, mood and affect in an immigrant population. The design employed in this study is similar to the used in other studies.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cristina Botella, PhD
  • Phone Number: 7639 +34 964 38 76 39
  • Email: botella@uji.es

Study Contact Backup

  • Name: Andreea M Dragomir-Davis, MA
  • Phone Number: 7649 +34 964 38 76 49
  • Email: andreea@uji.es

Study Locations

  • Spain
    • Castellón
      • Castellón de la Plana, Castellón, Spain, 12071
        • Recruiting
        • University Jaume I
        • Contact:
          • Cristina Botella, PhD
          • Phone Number: 7639 +34 964 38 76 39
          • Email: botella@uji.es
        • Contact:
          • Andreea M Dragomir-Davis, MA
          • Phone Number: 7649 +34 964 38 76 49
          • Email: andreea@uji.es
        • Principal Investigator:
          • Cristina Botella, PhD
        • Principal Investigator:
          • Azucena García-Palacios, PhD
        • Sub-Investigator:
          • Andreea M Dragomir-Davis, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Romanian immigrant in Spain
  • Sign a consent form stating their willingness to participate

Exclusion Criteria:

  • Presence of severe physical illness
  • Presence of severe psychological disorder
  • Be currently involved in another psychological treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Best Possible Self
Participants are asked to write and imagine about a future in which they have reached all their goals in four different domains: personal, professional, social and health. The participants are instructed to practice the BPS intervention for a month, 5 minutes/day.
Behavioral: Best Possible Self
Placebo Comparator: Daily Activities
Participants are asked to think and write about the activities carried out in the last 24 hours. The participants are instructed to practice the Daily Activities exercise for a month, 5 minutes/day.
Behavioral: Daily Activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Probability Task
Time Frame: 1 month
This scale measures positive and negative expectancies about future events. It consists of 20 statements referring to negative expectancies and 10 statements referring to positive expectancies. Participants answer on a 7-point scale (Not at all likely to occur - Extremely likely to occur). Some studies have found an appropriate levels of internal consistency for positive and negative expectancies (α=0.80-0.82 and 0.91, respectively)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Affect Scale
Time Frame: 1 month
This measure analyzes the levels of positive (PA) and negative affect (NA). The instrument consists of 20 items, 10 for each level of affect. Participants rate on a 5-point scale (Not at all - Extremely).
1 month
Beck Depression Inventory II
Time Frame: 1 month
This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and test-retest reliability of around 0.8.
1 month
Overall Anxiety Severity and Impairment Scale
Time Frame: 1 month
OASIS is a brief instrument consisting of 5 items that measure the frequency and severity of anxiety, as well as the level of avoidance and work/school/home and social interference that anxiety produces.
1 month
Dysfunctional Attitudes Scale
Time Frame: 1 month
1 month
Difficulties in Emotion Regulation Scale
Time Frame: 1 month
1 month
Life Orientation Test
Time Frame: 1 month
This scale measures positive and negative expectancies about future events. It consists of 20 statements referring to negative expectancies and 10 statements referring to positive expectancies. Participants answer on a 7-point scale (Not at all likely to occur - Extremely likely to occur). Some studies have found an appropriate levels of internal consistency for positive and negative expectancies (α=0.80-0.82 and 0.91, respectively).
1 month
Hope Scale
Time Frame: 1 month
1 month
Quality of Life Index
Time Frame: 1 month
It consists of 10 items that evaluate perceived well-being in different areas (physical, psychological/emotional, occupational functioning, interpersonal functioning, among others)
1 month
Ryff Scales of Psychological Well-Being
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Concordance Motivation
Time Frame: baseline
This questionnaire assess extrinsic and intrinsic motivation to practice the imagery exercise, rated on a 9-point scale ranging from 1 "not at all for this reason" to 9 "completely for this reason". SCM has been correlated withparticipants' frequency of practicing a daily imagery exercise and with self-reported imagery performance, a key aspect in self-applied interventions.
baseline
Multidimensional Scale of Perceived Discrimination
Time Frame: baseline
This scale is made up of 20 items that measure four aspects of perceived discrimination: blatant group discrimination, subtle group discrimination, blatant individual discrimination and subtle individual discrimination.
baseline
Social Support
Time Frame: baseline
This scale is an adapted version of the questionnaire designed by Gonzalez-Castro and Ubillos (2011). This questionnaire measures the social support received from other Romanians in Spain and from the Spanish people, in three areas: tangible social support (support in leisure activities), emotional support (care, love) and informational and instrumental support (help in addressing problems). In addition, the questionnaire measures the support received from those who live in the country of origin of the immigrant (1 = never receives support, 4 = receives a lot of support).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Jaume I

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UJaumeI013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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